Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

Phase 2CompletedNCT00262041

Novartis Vaccines524 enrolled

Overview

The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

524

Conditions

Prevention of Meningococcal Disease

Interventions

MenACWY-CRM conjugate vaccine, adjuvantedBIOLOGICAL

MenACWY-CRM conjugate vaccine, unadjuvantedBIOLOGICAL

MenACWY polysaccharide vaccineBIOLOGICAL

Eligibility

Sex: ALLMin age: 11 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adolescents between and including 11-17 years of age, who provide written informed consent Exclusion Criteria: * Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

Locations (3)

Unnamed facility

Rochester, Minnesota, United States

Unnamed facility

Pittsburgh, Pennsylvania, United States

Unnamed facility

Seattle, Washington, United States

Outcomes

Primary Outcomes

Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine

Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers \>1:4 directed against N meningitidis serogroups A, C, W and Y

Time frame: 1 month after vaccination

Secondary Outcomes

hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine

Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.

Time frame: 1 month after vaccination

Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine

Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.

Time frame: 12 months after vaccination

hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine

Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.

Data from ClinicalTrials.gov

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